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Trial record 100 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

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ClinicalTrials.gov Identifier: NCT02986880
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief 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.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.


Condition or disease Intervention/treatment Phase
Cervical Spasm Radiotherapy Side Effect Botulinum Toxin Drug: Botulinum toxin A Procedure: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
Study Start Date : June 2011
Actual Primary Completion Date : January 10, 2014
Actual Study Completion Date : January 10, 2014

Arm Intervention/treatment
Experimental: Group D1
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.
Drug: Botulinum toxin A
Experimental: Group D2
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.
Drug: Botulinum toxin A
Experimental: Group D3
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.
Drug: Botulinum toxin A
Experimental: Group A1
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.
Drug: Botulinum toxin A
Experimental: Group A2
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.
Drug: Botulinum toxin A
Experimental: Group A3
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.
Drug: Botulinum toxin A
Experimental: Group F1
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.
Drug: Botulinum toxin A
Experimental: Group F2
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.
Drug: Botulinum toxin A
Experimental: Group F3
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.
Drug: Botulinum toxin A
Placebo Comparator: Group P
Patients receiving placebo in the third muscles groups
Procedure: Placebo
Injection of sodium chloride (NaCl) 9/1000




Primary Outcome Measures :
  1. Cervical mobility degree [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • Women under effective contraception;
  • Patients benefiting from a national insurance scheme;
  • Patient having given a written consent.

Exclusion Criteria:

  • 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 ;
  • 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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986880


Locations
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France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Christine Bach Hopital Foch

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02986880     History of Changes
Other Study ID Numbers: 2011/08
2011-000889-35 ( EudraCT Number )
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dystonic Disorders
Dystonia
Contracture
Torticollis
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents