Spinal Cord InjuriesNCT01509885
Cyproheptadine and Chlorpromazine Effects on Spasticity
An observational study of Spinal Cord Injuries and Muscle Spasticity, run by University of Alberta at 1 site in Canada.
Trial summary
The main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. The investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Muscle Spasticity
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Nov 2012
- Phase
- Observational
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Spinal Cord Injury Patients
Who may be able to join
- Patients must have suffered a trauma to the spinal cord at least 6 months ago or longer. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score, as assessed by a physical therapist, greater than 1.
Who cannot join
- If patients have damage to the nervous system other than to the spinal cord
- Pregnant women
- Elderly Patients and debilitated patients
- Alcoholic Patients
- Patients with:
- Known or suspected allergy to the medication or its ingredients
Show all 37Show fewer
- Cardiovascular disease
- Hypotension
- Coronary artery disease
- Reduced liver or kidney function
- Comatose or depressed states due to CNS depressants
- Blood dyscrasias
- Bone marrow depression
- History of seizures
- Respiratory problems
- Hypocalcemia
- Monoamine oxidase inhibitor therapy
- Angle-closure glaucoma
- Stenosing peptic ulcer
- Symptomatic prostatic hypertrophy
- Bladder neck obstruction
- Pyloroduodenal obstruction
- History of bronchial asthma
- Increased intraocular pressure
- Hyperthyroidism
- Cardiovascular disease
- Hypertension
- Patients taking:
- Amphetamines
- Antihistamines-second generation
- Anticonvulsants
- Anticholinergics
- CNS depressants
- Antidepressants
- Hypotensive agents
- Levodopa
- Lithium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Cyproheptadine and Chlorpromazine Effects on Spasticity After Spinal Cord Injury
The main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. The investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with spinal cord injury. One of the neurons that the investigators study is the motoneuron that excites the muscles of the limbs to produce movement. Previously, the investigators have shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons during muscle spasms is mediated, in large part, by the activation of calcium currents in the human motoneuron. In human patients the investigators have used recordings from single muscle fibres to estimate the contribution of these calcium currents in activating the motoneuron during muscle spasms. In this proposal, the investigators study why motoneurons recover these calcium currents and self-sustained activity after chronic spinal cord injury. Because the calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this monoamine is greatly reduced after injury, the investigators examine if the calcium currents recover because the 5HT receptors become spontaneously active without the need for 5HT to bind to the receptor, which the investigators hypothesize to be one of the causes of spasticity after spinal cord injury. This research will pave the way to develop new pharmacological and rehabilitative therapies to both control spasticity after spinal cord injury and augment residual motor movements.
- Conditions
- Spinal Cord Injuries, Muscle Spasticity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Complete Spinal Cord Injured Subjects | Patients with no motor scores in their legs and suffering a complete spinal cord injury. | |
| Incomplete Spinal Cord Injured Subjects | Patient with some motor preservation below the injury and suffering an incomplete spinal cord injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneomuscular Reflex Responses
Tibialis anterior reflex responses evoked by stimulation of the medial arch of the foot will be measured before and after drug administration.
Measured: Change after drug intake at baseline, 30minutes, 60minutes, 90minutes and 120minutes
Paired motor unit recordings
We obtain paired motor unit recordings to determine changes in neuronal excitability after drug intake in incomplete spinal-cord injured subjects only.
Measured: Change at baseline and 30, 60, 90 and 120min after drug intake
Secondary outcomes (1)
Blood pressure and Heart rate
We measure blood pressure and heart rate to determine the safety of the drug during the experiment and whether we can continue safely.
Measured: Change at baseline and 30, 60, 90, 120 minutes after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica A Gorassini, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509885
- Sponsor's protocol ID
- Pro00020682
- Status last verified
- Nov 2012
- First submitted
- 10 Jan 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
Publications
Murray KC, Nakae A, Stephens MJ, Rank M, D'Amico J, Harvey PJ, Li X, Harris RL, Ballou EW, Anelli R, Heckman CJ, Mashimo T, Vavrek R, Sanelli L, Gorassini MA, Bennett DJ, Fouad K. Recovery of motoneuron and locomotor function after spinal cord injury depends on constitutive activity in 5-HT2C receptors. Nat Med. 2010 Jun;16(6):694-700. doi: 10.1038/nm.2160. Epub 2010 May 30.
PubMed 20512126
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Cyproheptadine and Chlorpromazine Effects on Spasticity After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01509885
- Acronym / sponsor ID
- Pro00020682
- Conditions
- Spinal Cord Injuries, Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Jan 2012 (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.
The main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. The investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with spinal cord injury. One of the neurons that the investigators study is the motoneuron that excites the muscles of the limbs to produce movement. Previously, the investigators have shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons during muscle spasms is mediated, in large part, by the activation of calcium currents in the human motoneuron. In human patients the investigators have used recordings from single muscle fibres to estimate the contribution of these calcium currents in activating the motoneuron during muscle spasms. In this proposal, the investigators study why motoneurons recover these calcium currents and self-sustained activity after chronic spinal cord injury. Because the calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this monoamine is greatly reduced after injury, the investigators examine if the calcium currents recover because the 5HT receptors become spontaneously active without the need for 5HT to bind to the receptor, which the investigators hypothesize to be one of the causes of spasticity after spinal cord injury. This research will pave the way to develop new pharmacological and rehabilitative therapies to both control spasticity after spinal cord injury and augment residual motor movements.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Spinal Cord Injured Subjects | – | –Patients with no motor scores in their legs and suffering a complete spinal cord injury. |
| Incomplete Spinal Cord Injured Subjects | – | –Patient with some motor preservation below the injury and suffering an incomplete spinal cord injury. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal Cord Injury Patients
Key inclusion criteria (1 listed)
- Patients must have suffered a trauma to the spinal cord at least 6 months ago or longer. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score, as assessed by a physical therapist, greater than 1.
Key exclusion criteria (37 listed)
- If patients have damage to the nervous system other than to the spinal cord
- Pregnant women
- Elderly Patients and debilitated patients
- Alcoholic Patients
- Patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cutaneomuscular Reflex Responses
Time frame: Change after drug intake at baseline, 30minutes, 60minutes, 90minutes and 120minutes
Tibialis anterior reflex responses evoked by stimulation of the medial arch of the foot will be measured before and after drug administration.
Paired motor unit recordings
Time frame: Change at baseline and 30, 60, 90 and 120min after drug intake
We obtain paired motor unit recordings to determine changes in neuronal excitability after drug intake in incomplete spinal-cord injured subjects only.
1 secondary outcome
Blood pressure and Heart rate
Time frame: Change at baseline and 30, 60, 90, 120 minutes after drug intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Results publication: PubMed 20512126Murray KC, Nakae A, Stephens MJ, Rank M, D'Amico J, Harvey PJ, Li X, Harris RL, Ballou EW, Anelli R, Heckman CJ, Mashimo T, Vavrek R, Sanelli L, Gorassini MA, Bennett DJ, Fouad K. Recovery of motoneuron and locomotor function after spinal cord injury depends on constitutive activity in 5-HT2C receptors. Nat Med. 2010 Jun;16(6):694-700. doi: 10.1038/nm.2160. Epub 2010 May 30.
- Related InfoLink provided by the sponsor.
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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.
Monica A Gorassini, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Muscle Spasticity, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 37 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: finished, as of the sponsor's last update on 20 Nov 2012. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cutaneomuscular Reflex Responses (time frame: Change after drug intake at baseline, 30minutes, 60minutes, 90minutes and 120minutes). The study lists 2 primary outcomes in all. 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 NCT01509885, which also lists 1 linked publication.
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 20 Nov 2012.