Muscle SpasticityPhase 2NCT00532532
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis
A Phase 2 study testing tolperisone HCl in people with Muscle Spasticity, run by Avigen at 28 sites in 5 countries.
Trial summary
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes: 1. To determine whether AV650 is safe for patients with multiple sclerosis; 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- tolperisone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 18 and 70 years of age (inclusive)
- Signed and dated informed consent
- Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
- Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
- Stable MS for at least 30 days before screening
- Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter
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- If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.)
- Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
- If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
- If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
Who cannot join
- Subjects who have participated in another research study within 90 days of Screening
- Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
- Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
- Use of tolperisone HCl within 30 days of screening
- Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
- Spasticity due to neurological disorders other than MS
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- Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study
- Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline
- History of alcohol or substance abuse within one year of Screening
- Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS
- Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction
- QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator
- Diastolic blood pressure <50mmHg or >105mmHg; heart rate <50 beats per minute (bpm) or >110bpm, after 3 minutes in a sitting position; heart rate by ECG <50bpm or >110bpm
- History of epilepsy (except childhood febrile seizures)
- Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment)
- Female subject who is pregnant, nursing, or planning pregnancy during the course of the study
- Scheduled elective surgery or other procedures requiring general anesthesia during the study
- Subject who is terminally ill in the judgment of the Investigator
- Subject who is inappropriate for placebo medication in the judgment of the Investigator
- Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma
- Exacerbation of MS within 30 days of Baseline
- Regular levo-dopa therapy within 7 days of randomization
- Subjects taking antiarrhythmic medications
- Donation of blood during the study
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
Germany9 sites
Facharzt fur Neurologie
Bad Saarow, 15526
Facharztin fur Neurologie und Psychiatrie
Berlin, 12555
Facharzt fur Neurologie und Psychiatrie
Berlin, 13053
Private practice
Berlin, D-13156
Neurological practice
Bochum, 44805
Neurological practice
Cologne, 50767
Neuro-Consil GmbH
Düsseldorf, 40212
X-pert-med GmbH
Gräfelfing, 82166
Asklepios Klinik Nord-Heidberg
Hamburg, D022417
Ukraine8 sites
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008
Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 1)
Kharkiv, 61018
Central Clinical Hospital Ukrzalinznytsi (Dept. Neur. No. 3)
Kharkiv, 61018
Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine
Kharkiv, 61068
Institute of Clinical Radiology of the Scientific Centre of Radiation Medicine of the AMS of Ukraine
Kyiv, 03115
Odesa Regional Psychoneurological Dispensary
Odesa, 65014
M.O.Semashko Republican Clinical Hospital
Simferopol, 95017
Uzhgorod Regional Centre of Neurosurgery and Neurology
Uzhhorod, 88018
Russia5 sites
City Hospital #33
Nizhny Novgorod, 603076
Regional Clinical Hospital named Semashko
Nizhny Novgorod, 603126
Institute of Human Brain
Saint Petersburg, 194291
Leningrad Regional Clinical Hospital
Saint Petersburg, 197376
Nikolaevskaya Hospital, Complex Rehabilitation Department
Saint Petersburg, 198510
Czechia4 sites
Annes University Hospital
Brno, 65691
University Hospital Hradec Kralove
Hradec Králové, 50005
University Hospital Plzen
Pilsen, 30460
University Hospital Motol
Prague, 15006
Serbia2 sites
Clinical Center of Serbia Institute of Neurology
Belgrade, 11000
Clinical Center Nis Clinic of Neurology
Niš, 18000
About this study
Official title: AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:
- To determine whether AV650 is safe for patients with multiple sclerosis;
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
- To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).
- Conditions
- Muscle Spasticity
- Being tested
- tolperisone HCl
- Keywords
- Multiple sclerosis
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolperisone HClDrug
Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
tolperisone HClDrug
High dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
tolperisone HClDrug
Placebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AV650 low dose Receives: Drug: tolperisone HCl |
| 2 | Experimental | AV650 high dose Receives: Drug: tolperisone HCl |
| 3 | Experimental | Placebo Receives: Drug: tolperisone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS
Measured: 38 weeks
Secondary outcomes (1)
To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Glenn Morrison, MSc, PhD, Study director, Avigen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532532
- Sponsor's protocol ID
- AV650-018
- Status last verified
- Nov 2008
- First submitted
- 18 Sep 2007
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00532532
- Acronym / sponsor ID
- AV650-018
- Conditions
- Muscle Spasticity
- Keywords
- Multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AvigenIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity associated with multiple sclerosis. This study has three purposes:
- To determine whether AV650 is safe for patients with multiple sclerosis;
- To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
- To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tolperisone HClAV650 low dose |
| 2 | Experimental | Drug: tolperisone HClAV650 high dose |
| 3 | Experimental | Drug: tolperisone HClPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects between 18 and 70 years of age (inclusive)
- Signed and dated informed consent
- Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
- Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
- Stable MS for at least 30 days before screening
Key exclusion criteria (24 listed)
- Subjects who have participated in another research study within 90 days of Screening
- Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
- Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
- Use of tolperisone HCl within 30 days of screening
- Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
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 |
|---|---|---|
| tolperisone HClLow dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks | Drug | 1 |
| tolperisone HClHigh dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks | Drug | 2 |
| tolperisone HClPlacebo three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks | Drug | 3 |
Primary outcome
To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS
Time frame: 38 weeks
1 secondary outcome
To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels
Time frame: 38 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2008.
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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.
Glenn Morrison, MSc, PhD study director
Avigen, Inc.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tolperisone HCl in people with Muscle Spasticity, run by Avigen at 28 sites in 5 countries.
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 10 inclusion and 24 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 4 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Ukraine, Russia, Czechia, Serbia. 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. 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?
The study was stopped early. Results are not available in the source record.
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?
To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS (time frame: 38 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2008.