Focal DystoniaPhase 2NCT01750346
Acetyl Hexapeptide-8 for Blepharospasm
A Phase 2 study testing Topical acetyl hexapeptide-8 in people with Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Blepharospasm is caused by excessive contraction of the muscles that close the eye. One treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT, acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Dystonia
- What is being tested?
- Topical acetyl hexapeptide-8
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary blepharospasm diagnosed or confirmed by a Movement Disorders Neurologist, confirmed at the initial visit by a study investigator.
- Individuals off BoNT therapy for at least 4 months will be eligible for this study.
- Severity prompting need for treatment as determined by clinical judgment
- At least a score of 4 on the JBRS
- At least a score of 8 on the BDS
- Duration of symptoms of at least 1 year, without subjective active progression by patient report
- Concomitant therapy allowed, except injectable BoNT therapy, provided the doses remain stable throughout the study period
- Adult patients (> 18)
Who cannot join
- Blepharospasm associated with generalized or extensive regional dystonia
- Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed as judged by recruiting physician
- Local eyelid pathology precluding topical treatment
- Received BoNT within 4 months prior to enrollment
- Continued benefit from a prior BoNT injection (by history and self assesment) Current use of cosmetic wrinkle creams
- Prior myectomy procedure excluded
Show all 12Show fewer
- Pregnant women excluded. Barrier contraception will be used throughout the study for women of childbearing age, as it is not known how the use of hormonal contraceptives may interact with the study substance. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at the initial visit and periodically every 2 months for the duration of the study. Barrier contraception will be deemed necessary for the duration of the study and none after.
- Use of other treatments for blepharospasm allowed if the doses remain constant
- Allergy/sensitivity to study substance or vehicle.
- Active drug or alcohol abuse or dependence
- Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; active heart disease needing immediate intervention; active respiratory disease needing intervention; known or observed eye pathology; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- Cognitive inability to independently use cr(SqrRoot)(Registered Trademark)me use safely.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Placebo Controlled Double Blind Study of Acetyl Hexapeptide-8 in Treatment of Blepharospasm
Background:
- Blepharospasm is caused by excessive contraction of the muscles that close the eye. One treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT, acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream. AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles. Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see if it can be a more effective treatment.
Read more
Objectives:
- To see if AH-8 cream can improve the symptoms of blepharospasm.
Eligibility:
- Individuals at least 18 years of age who have blepharospasm that is severe enough to require treatment.
Design:
- This study will involve up to eight study visits.
- Participants will be screened with a physical exam and medical history. They will answer questions about their symptoms. They will also have a blink test to see how severe the blepharospasm is. At this visit, participants will receive one of three types of cream. One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the other will be a placebo (no AH-8).
- One month later, participants will have a followup visit, with tests similar to the first visit. They will also receive more of the cream.
- One month later, participants will have another visit with the same tests. They will be videotaped at this visit to study their facial movements. Those who have responded to the treatment will continue to use the cream. Those who have not responded will be offered the chance to have BoNT injections, and will stop taking the cream.
- One month later, participants who had BoNT injections will have a final visit to check for possible side effects. Those who continued to take the cream will continue on the study.
- The fifth and sixth visits will involve the same tests as before. At the seventh visit, remaining participants will be offered the chance to have BoNT injections, and will stop taking the cream.
- The final visit will check for any side effects from the cream or the injections.
Read the detailed description
OBJECTIVE:
Test the efficacy of topical AH-8 in blepharospasm treatment.
DESIGN:
This is a randomized, double blind, placebo-controlled study, phase II single center clinical trial. Patients with primary blepharospasm at least 4 months off BoNT therapy with no benefit from last BoNT injection by history and self assesment will be included. We will use 3 study arms placebo and 2 different doses (as concentrations of the AH-8 active substance in the topical preparation). An extension phase is planned after the initial phase.
The patients will have a baseline screening visit, including measurement of the outcome variables, then begin the study intervention. They will have 2 subsequent visits at month 1 and month 2. After this visit, the patients who do not have significant benefit and wish to have an alternative therapy (GROUP 1) will receive BoNT injections according to best practice standards. These patients will then be assessed 1 month later (peak effect of BoNT therapy) and the effect will be compared with the AH-8 effect. The patients who have significant benefit (GROUP 2) will continue therapy for another 4 months (total of 6 months), and will have another assessment at that point. Afterwards the patients will be offered BoNT injections according to best practice standards, similar to Group 1 above, and another assessment will be made one month later (month 7) to compare the effects with AH-8 effects.
OUTCOME MEASURES:
Primary outcome variable: the Jankovic Blepharospasm Rating Scale at month 2.
Secondary outcome variables:
- the Jankovic Blepharospasm Rating Scale at month 1
- the Blepharospasm Disability Scale at month 1
- the Blepharospasm Disability Scale at month 2
- the difference in JBRS at month 3 time point (after BoNT injection) in patients receiving BoNT
- JBRS score at 6 months for patients not receiving BoNT at month 2 (Group 2)
- the difference in JBRS between month 6 and month 7 time point (after BoNT injection) in Group 2 patients
- Blink reflex measures at month 2
Non-parametric comparison (Wilcoxon Mann-Whitney test) of the primary and secondary variables before and after the intervention will be used for statistical analysis. Additional multivariate analysis will explore the influence of other factors (age, gender, disease duration).
Interventions and Duration
Twice daily application of active substance or placebo. Two active substance concentrations, 0.025% and 0.05% AH-8 will be used.
Each subject will be in the study a total of at least 3 months, followed by additional up to 4 months in the second phase for the group 2 patients.
Sample Size and Population
There will be 8 patients per arm, for a total study population of 24. The power calculation for a power of 80%, for a 2-tailed alpha of 0.05, to be able to detect a change of 2 points on the JBRS requires 8 patients per arm. This calculation was based on independent calculation for each dose of the active agent against placebo.
The subjects included will be patients with primary blepharospasm, not currently treated with BoNT (de novo diagnosed patients), but who subjectively express a wish for treatment intervention, with at least one year history from symptom onset, without perceived active change in symptoms by history. Patients with blepharospasm as part of a generalized dystonia or due to a different neurologic condition will be excluded.
Randomization and blinding to be performed by the NIH research pharmacy.
- Conditions
- Focal Dystonia
- Being tested
- Topical acetyl hexapeptide-8, Placebo
- Keywords
- Blepharospasm, Treatment, Dystonia, Acetyl-Hexapeptide
- Medical subject headings
- Dystonic Disorders, Blepharospasm, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical acetyl hexapeptide-8Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.05% AH-8 | Active comparator | Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline. Receives: Drug: Topical acetyl hexapeptide-8 |
| 0.025% AH-8 | Active comparator | Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline. Receives: Drug: Topical acetyl hexapeptide-8 |
| Placebo | Placebo comparator | Participants in the Placebo arm received the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Jankovic Blepharospasm Rating Scale at 2 Month
The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Measured: 2 months
Secondary outcomes (6)
The Jankovic Blepharospasm Rating Scale at 1 Month
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Measured: 1 month
The Blepharospasm Disability Scale at 1 Month
The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.
Measured: 1 month
The Blepharospasm Disability Scale at 2 Months
The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.
Measured: 2 months
The Jankovic Blepharospasm Rating Scale at 3 Months
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Measured: 3 months
The Jankovic Blepharospasm Rating Scale at 6 Months
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Measured: 6 months
The Jankovic Blepharospasm Rating Scale at 7 Months
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focal DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Codrin I Lungu, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750346
- Sponsor's protocol ID
- 130022
- Other IDs
- 13-N-0022
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2012
- Last updated
- 10 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ben Simon GJ, McCann JD. Benign essential blepharospasm. Int Ophthalmol Clin. 2005 Summer;45(3):49-75. doi: 10.1097/01.iio.0000167238.26526.a8. No abstract available.
PubMed 15970766Defazio G, Livrea P. Primary blepharospasm: diagnosis and management. Drugs. 2004;64(3):237-44. doi: 10.2165/00003495-200464030-00002.
PubMed 14871168Defazio G, Livrea P. Epidemiology of primary blepharospasm. Mov Disord. 2002 Jan;17(1):7-12. doi: 10.1002/mds.1275.
PubMed 11835433
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Double Blind Study of Acetyl Hexapeptide-8 in Treatment of Blepharospasm
- ClinicalTrials.gov ID
- NCT01750346
- Acronym / sponsor ID
- 130022
- Conditions
- Focal Dystonia
- Keywords
- Blepharospasm, Treatment, Dystonia, Acetyl-Hexapeptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Nov 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 10 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Blepharospasm is caused by excessive contraction of the muscles that close the eye. One treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT, acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream. AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles. Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see if it can be a more effective treatment.
Objectives:
- To see if AH-8 cream can improve the symptoms of blepharospasm.
Eligibility:
- Individuals at least 18 years of age who have blepharospasm that is severe enough to require treatment.
Design:
- This study will involve up to eight study visits.
- Participants will be screened with a physical exam and medical history. They will answer questions about their symptoms. They will also have a blink test to see how severe the blepharospasm is. At this visit, participants will receive one of three types of cream. One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the other will be a placebo (no AH-8).
- One month later, participants will have a followup visit, with tests similar to the first visit. They will also receive more of the cream.
- One month later, participants will have another visit with the same tests. They will be videotaped at this visit to study their facial movements. Those who have responded to the treatment will continue to use the cream. Those who have not responded will be offered the chance to have BoNT injections, and will stop taking the cream.
- One month later, participants who had BoNT injections will have a final visit to check for possible side effects. Those who continued to take the cream will continue on the study.
- The fifth and sixth visits will involve the same tests as before. At the seventh visit, remaining participants will be offered the chance to have BoNT injections, and will stop taking the cream.
- The final visit will check for any side effects from the cream or the injections.
Detailed description
OBJECTIVE:
Test the efficacy of topical AH-8 in blepharospasm treatment.
DESIGN:
This is a randomized, double blind, placebo-controlled study, phase II single center clinical trial. Patients with primary blepharospasm at least 4 months off BoNT therapy with no benefit from last BoNT injection by history and self assesment will be included. We will use 3 study arms placebo and 2 different doses (as concentrations of the AH-8 active substance in the topical preparation). An extension phase is planned after the initial phase.
The patients will have a baseline screening visit, including measurement of the outcome variables, then begin the study intervention. They will have 2 subsequent visits at month 1 and month 2. After this visit, the patients who do not have significant benefit and wish to have an alternative therapy (GROUP 1) will receive BoNT injections according to best practice standards. These patients will then be assessed 1 month later (peak effect of BoNT therapy) and the effect will be compared with the AH-8 effect. The patients who have significant benefit (GROUP 2) will continue therapy for another 4 months (total of 6 months), and will have another assessment at that point. Afterwards the patients will be offered BoNT injections according to best practice standards, similar to Group 1 above, and another assessment will be made one month later (month 7) to compare the effects with AH-8 effects.
OUTCOME MEASURES:
Primary outcome variable: the Jankovic Blepharospasm Rating Scale at month 2.
Secondary outcome variables:
- the Jankovic Blepharospasm Rating Scale at month 1
- the Blepharospasm Disability Scale at month 1
- the Blepharospasm Disability Scale at month 2
- the difference in JBRS at month 3 time point (after BoNT injection) in patients receiving BoNT
- JBRS score at 6 months for patients not receiving BoNT at month 2 (Group 2)
- the difference in JBRS between month 6 and month 7 time point (after BoNT injection) in Group 2 patients
- Blink reflex measures at month 2
Non-parametric comparison (Wilcoxon Mann-Whitney test) of the primary and secondary variables before and after the intervention will be used for statistical analysis. Additional multivariate analysis will explore the influence of other factors (age, gender, disease duration).
Interventions and Duration
Twice daily application of active substance or placebo. Two active substance concentrations, 0.025% and 0.05% AH-8 will be used.
Each subject will be in the study a total of at least 3 months, followed by additional up to 4 months in the second phase for the group 2 patients.
Sample Size and Population
There will be 8 patients per arm, for a total study population of 24. The power calculation for a power of 80%, for a 2-tailed alpha of 0.05, to be able to detect a change of 2 points on the JBRS requires 8 patients per arm. This calculation was based on independent calculation for each dose of the active agent against placebo.
The subjects included will be patients with primary blepharospasm, not currently treated with BoNT (de novo diagnosed patients), but who subjectively express a wish for treatment intervention, with at least one year history from symptom onset, without perceived active change in symptoms by history. Patients with blepharospasm as part of a generalized dystonia or due to a different neurologic condition will be excluded.
Randomization and blinding to be performed by the NIH research pharmacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.05% AH-8 | Active comparator | Drug: Topical acetyl hexapeptide-8Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline. |
| 0.025% AH-8 | Active comparator | Drug: Topical acetyl hexapeptide-8Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in the Placebo arm received the placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary blepharospasm diagnosed or confirmed by a Movement Disorders Neurologist, confirmed at the initial visit by a study investigator.
- Individuals off BoNT therapy for at least 4 months will be eligible for this study.
Key exclusion criteria (12 listed)
- Blepharospasm associated with generalized or extensive regional dystonia
- Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed as judged by recruiting physician
- Local eyelid pathology precluding topical treatment
- Received BoNT within 4 months prior to enrollment
- Continued benefit from a prior BoNT injection (by history and self assesment) Current use of cosmetic wrinkle creams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical acetyl hexapeptide-8 | Drug | 0.025% AH-8, 0.05% AH-8 |
| Placebo | Drug | Placebo |
Primary outcome
The Jankovic Blepharospasm Rating Scale at 2 Month
Time frame: 2 months
The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
6 secondary outcomes
The Jankovic Blepharospasm Rating Scale at 1 Month
Time frame: 1 month
The Blepharospasm Disability Scale at 1 Month
Time frame: 1 month
The Blepharospasm Disability Scale at 2 Months
Time frame: 2 months
The Jankovic Blepharospasm Rating Scale at 3 Months
Time frame: 3 months
The Jankovic Blepharospasm Rating Scale at 6 Months
Time frame: 6 months
The Jankovic Blepharospasm Rating Scale at 7 Months
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15970766Ben Simon GJ, McCann JD. Benign essential blepharospasm. Int Ophthalmol Clin. 2005 Summer;45(3):49-75. doi: 10.1097/01.iio.0000167238.26526.a8. No abstract available.
- Background: PubMed 14871168Defazio G, Livrea P. Primary blepharospasm: diagnosis and management. Drugs. 2004;64(3):237-44. doi: 10.2165/00003495-200464030-00002.
- Background: PubMed 11835433Defazio G, Livrea P. Epidemiology of primary blepharospasm. Mov Disord. 2002 Jan;17(1):7-12. doi: 10.1002/mds.1275.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Codrin I Lungu, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical acetyl hexapeptide-8 in people with Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Jankovic Blepharospasm Rating Scale at 2 Month (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.