Cervical SpasmPhase 2NCT02986880
Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
A Phase 2 study testing Botulinum toxin A in people with Cervical Spasm and Radiotherapy Side Effect, run by Hopital Foch at 1 site in France.
Trial summary
The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spasm, Radiotherapy Side Effect, Botulinum Toxin
- What is being tested?
- Botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to 10 Jan 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 18 to 75 years old;
- malignant Tumor of aerodigestive ways, in forgiveness;
- Treatment containing the external radiotherapy ended since > 6 months
- Life expectancy > 6 months;
- patient complaining from cervical spasms with functional disability;
- Negative Pregnancy test;
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- Women under effective contraception;
- Patients benefiting from a national insurance scheme;
- Patient having given a written consent.
Who cannot join
- Cervico-facial Surgery with reconstruction by pedicled flap
- Implantable Chamber with catheter in the internal jugular vein near the spasm;
- Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
- Disorder generalized by the muscular activity (ex myasthenia);
- Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
- Previous cervical injection of botulinum toxin ;
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- Local Infection at the level of one of the sites proposed for injection;
- Histories of epilepsy;
- Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its excipients;
- Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation;
- Patients for whom a surgical operation is planned in the zone interested in the treatment
- Pregnant or breast-feeding Women;
- Patients for whom questionnaires will not be assessable (handicaps of communication, patient not speaking French, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.
The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.
- Conditions
- Cervical Spasm, Radiotherapy Side Effect, Botulinum Toxin
- Being tested
- Botulinum toxin A, Placebo
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
PlaceboProcedure or surgery
Injection of sodium chloride (NaCl) 9/1000
| Study group | Role | What they receive |
|---|---|---|
| Group D1 | Experimental | Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U. Receives: Drug: Botulinum toxin A |
| Group D2 | Experimental | Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 60 units (U) at injection point, totalling 240 U. Receives: Drug: Botulinum toxin A |
| Group D3 | Experimental | Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 100 units (U) at injection point, totalling 400 U. Receives: Drug: Botulinum toxin A |
| Group A1 | Experimental | Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 30 units (U) at injection point, totalling 180 U. Receives: Drug: Botulinum toxin A |
| Group A2 | Experimental | Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 60 units (U) at injection point, totalling 360 U. Receives: Drug: Botulinum toxin A |
| Group A3 | Experimental | Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 100 units (U) at injection point, totalling 600 U. Receives: Drug: Botulinum toxin A |
| Group F1 | Experimental | Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U. Receives: Drug: Botulinum toxin A |
| Group F2 | Experimental | Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U. Receives: Drug: Botulinum toxin A |
| Group F3 | Experimental | Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U. Receives: Drug: Botulinum toxin A |
| Group P | Placebo comparator | Patients receiving placebo in the third muscles groups Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical mobility degree
Measured: 6 months
Secondary outcomes (1)
Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startJun 2011
- Primary completion10 Jan 2014
- Study completion10 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpasmStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Bach, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986880
- Sponsor's protocol ID
- 2011/08
- Other IDs
- 2011-000889-35
- Status last verified
- May 2017
- First submitted
- 6 Dec 2016
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
- ClinicalTrials.gov ID
- NCT02986880
- Acronym / sponsor ID
- 2011/08
- Conditions
- Cervical Spasm, Radiotherapy Side Effect, Botulinum Toxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 10 Jan 2014 (actual)
- Study completion
- 10 Jan 2014 (actual)
- First posted
- 8 Dec 2016 (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 objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.
The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group D1 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U. |
| Group D2 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 60 units (U) at injection point, totalling 240 U. |
| Group D3 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 100 units (U) at injection point, totalling 400 U. |
| Group A1 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 30 units (U) at injection point, totalling 180 U. |
| Group A2 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 60 units (U) at injection point, totalling 360 U. |
| Group A3 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 100 units (U) at injection point, totalling 600 U. |
| Group F1 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U. |
| Group F2 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U. |
| Group F3 | Experimental | Drug: Botulinum toxin APatients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U. |
| Group P | Placebo comparator | Procedure: PlaceboPatients receiving placebo in the third muscles groups |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients from 18 to 75 years old;
- malignant Tumor of aerodigestive ways, in forgiveness;
- Treatment containing the external radiotherapy ended since > 6 months
- Life expectancy > 6 months;
- patient complaining from cervical spasms with functional disability;
Key exclusion criteria (13 listed)
- Cervico-facial Surgery with reconstruction by pedicled flap
- Implantable Chamber with catheter in the internal jugular vein near the spasm;
- Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
- Disorder generalized by the muscular activity (ex myasthenia);
- Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
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 |
|---|---|---|
| Botulinum toxin A | Drug | Group A1, Group A2, Group A3, Group D1, Group D2, Group D3, Group F1, Group F2, Group F3 |
| PlaceboInjection of sodium chloride (NaCl) 9/1000 | Procedure or surgery | Group P |
Primary outcome
Cervical mobility degree
Time frame: 6 months
1 secondary outcome
Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)
Time frame: 6 months
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 25 May 2017.
- Individual participant dataSharing planned: No
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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.
Christine Bach principal investigator
Hopital Foch
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 Botulinum toxin A in people with Cervical Spasm and Radiotherapy Side Effect, run by Hopital Foch at 1 site in France.
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 9 inclusion and 13 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 25 May 2017. 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 France. 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?
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?
Cervical mobility degree (time frame: 6 months). 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 25 May 2017.