Freezing of GateNCT06094309
Effectiveness of Botulinum Toxin in Freezing of Gate in Parkinson's Disease Walking in Parkinson's Disease.
A study testing Botulinum toxin type A injection in people with Freezing of Gate and Parkinson Disease, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial summary
Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Freezing of Gate, Parkinson Disease, Botulinum Toxin
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: people with idiopathic Parkinson's disease with the presence of gait freezing, which scores > 1 at point 2.13 of the MDS-UPDRS8 scale and is responsive to cueing techniques, with severity of Parkinson's disease classified between 3 and 4 on the Hoehn \& Yahr9 scale.
Exclusion Criteria: previous exposure to toxin therapy, alteration of therapy for PD during the course of the study, cognitive impairment with MMSE10 < 10.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Pilot Study Evaluating Effectiveness of Botulinum Toxin Type A in Freezing Walking in Parkinson's Disease
Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. In this sense, and through empirical experience, it has been noted that freezing responds to cueing techniques (visual, sensory motor, auditory tricks, among others) which suggests a similarity with dystonic pathology. This similarity could be the basis of a common response to botulinum toxin (BT). Objectives: This study aims to understand whether BT is an effective therapy for freezing gait in patients with Parkinson's disease. Methodology: This is a prospective parallel study with therapeutic intervention, controlled by placebo, double blind. The randomization of groups will be stratified. The population will be recruited from from the CHLC movement disorders consultation, and that meets the following inclusion criteria: Parkinson's disease with freezing of gait, scoring > 1 at point 2.13 on the scale MDS-UPDRS and be responsive to cueing techniques, with severity of Parkinson's disease rated 3 or 4 on the Hoehn \& Yahr scale. The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk.
Read the detailed description
Study with therapeutic intervention, placebo-controlled, double-blind, with stratified randomization using the minimization method. The variables to consider by this method will be binary variables and three will be considered: the severity of the freezing (degree 2 freezing / degree 3 and 4 freezing)8, the severity of the disease Parkinson's (Hoehn \& Yahr (H\&Y) stage 3 / H\&Y stage 4)9 and cognitive capacity (Mini-Mental State Examination (MMSE) 10-23 / MMSE 24-30)10.
People with Parkinson's disease in advanced stages, with freezing of gait frequent, responsive to cueing techniques, followed in consultation for diseases of the movement at CHULC, with the participation of doctors specializing in diseases of movement. All eligible participants will be required to complete the consent informed prior to their inclusion in the study.
Inclusion criteria: people with idiopathic Parkinson's disease with the presence of gait freezing, which scores > 1 at point 2.13 of the MDS-UPDRS8 scale and is responsive to cueing techniques, with severity of Parkinson's disease classified between 3 and 4 on the Hoehn \& Yahr9 scale.
Exclusion criteria: previous exposure to toxin therapy, alteration of therapy for PD during the course of the study, cognitive impairment with MMSE10 < 10.
There will be two distinct modalities of observation and assessment of patients: in person, every month for 4 months, with observation of the patient and application of MDS-UPDRS8 scale, Timed Up \& Go (TUG) scale11, and Two Minutes Walk scale12 and telephone, every week for 4 months, with the application of a questionnaire on the freezing and another about the impression of improvement. Both assessment modalities will be carried out by doctors from the Neurology service.
- Observation of the patient before administration of BT therapy and every month, on a scheduled basis, at the same time, 12 hours after suspension of the levodopa therapy (T0, T1M, T2M, T3M, T4M) and classification of scales Timed Up \& Go11 and Two Minutes Walk12;
- Application of the FOGQ13 and SCGIC14 questionnaires before administration of the therapy and every week, via telephone, to the patient (T0, T1S, T2S, T3S, T1M, T5S, T6S, T7S, T2M, T9S, T10S, T11S, T3M, T13S, T14S, T15S, T4M).
- Conditions
- Freezing of Gate, Parkinson Disease, Botulinum Toxin
- Being tested
- Botulinum toxin type A injection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: botulinum toxin | Active comparator | The botulinum toxin injection will be carried out by a doctor with experience in this therapeutic modality, which in turn is not part of the group of doctors who observe patients in the initial and subsequent phases. 100 Units (U) of botulinum toxin type A, in each lower limb (200 U in total), in muscle proximal thigh, once, at a moment that will be defined as T0. This group of 10 participans. Receives: Drug: Botulinum toxin type A injection |
| Active Comparator: Placebo | Placebo comparator | In the control group, patients will be subject to the same protocol, with the difference in that the injections will be saline, although they look the same on the outside. You doctors carrying out therapy and evaluating progress during face-to-face visits will not have access to the distribution of groups. This group of 10 participans. Receives: Drug: Botulinum toxin type A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation Unified Parkinson's Disease Rating Scale (MDS-UPDRS8)
which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
Measured: for 4 months after the study
Variation Escala "Timed Up & Go"11
20% improvement in completion time in any reevaluations;
Measured: for 4 months after the study
Variation Escala Two Minutes Walk12
20% improvement in the distance covered in any reevaluations;
Measured: for 4 months after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of GateStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094309
- Sponsor's protocol ID
- CHULC.CI.431.2022
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study Evaluating Effectiveness of Botulinum Toxin Type A in Freezing Walking in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06094309
- Acronym / sponsor ID
- CHULC.CI.431.2022
- Conditions
- Freezing of Gate, Parkinson Disease, Botulinum Toxin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- 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.
Freezing of gait is a symptom of Parkinson's disease (PD) that becomes more evident with the evolution of the disease, and which presents an important difference compared to the other signs and symptoms: does not respond adequately to dopaminergic therapy, which calls into question its pathophysiology. In this sense, and through empirical experience, it has been noted that freezing responds to cueing techniques (visual, sensory motor, auditory tricks, among others) which suggests a similarity with dystonic pathology. This similarity could be the basis of a common response to botulinum toxin (BT). Objectives: This study aims to understand whether BT is an effective therapy for freezing gait in patients with Parkinson's disease. Methodology: This is a prospective parallel study with therapeutic intervention, controlled by placebo, double blind. The randomization of groups will be stratified. The population will be recruited from from the CHLC movement disorders consultation, and that meets the following inclusion criteria: Parkinson's disease with freezing of gait, scoring > 1 at point 2.13 on the scale MDS-UPDRS and be responsive to cueing techniques, with severity of Parkinson's disease rated 3 or 4 on the Hoehn \& Yahr scale. The BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk.
Detailed description
Study with therapeutic intervention, placebo-controlled, double-blind, with stratified randomization using the minimization method. The variables to consider by this method will be binary variables and three will be considered: the severity of the freezing (degree 2 freezing / degree 3 and 4 freezing)8, the severity of the disease Parkinson's (Hoehn \& Yahr (H\&Y) stage 3 / H\&Y stage 4)9 and cognitive capacity (Mini-Mental State Examination (MMSE) 10-23 / MMSE 24-30)10.
People with Parkinson's disease in advanced stages, with freezing of gait frequent, responsive to cueing techniques, followed in consultation for diseases of the movement at CHULC, with the participation of doctors specializing in diseases of movement. All eligible participants will be required to complete the consent informed prior to their inclusion in the study.
Inclusion criteria: people with idiopathic Parkinson's disease with the presence of gait freezing, which scores > 1 at point 2.13 of the MDS-UPDRS8 scale and is responsive to cueing techniques, with severity of Parkinson's disease classified between 3 and 4 on the Hoehn \& Yahr9 scale.
Exclusion criteria: previous exposure to toxin therapy, alteration of therapy for PD during the course of the study, cognitive impairment with MMSE10 < 10.
There will be two distinct modalities of observation and assessment of patients: in person, every month for 4 months, with observation of the patient and application of MDS-UPDRS8 scale, Timed Up \& Go (TUG) scale11, and Two Minutes Walk scale12 and telephone, every week for 4 months, with the application of a questionnaire on the freezing and another about the impression of improvement. Both assessment modalities will be carried out by doctors from the Neurology service.
- Observation of the patient before administration of BT therapy and every month, on a scheduled basis, at the same time, 12 hours after suspension of the levodopa therapy (T0, T1M, T2M, T3M, T4M) and classification of scales Timed Up \& Go11 and Two Minutes Walk12;
- Application of the FOGQ13 and SCGIC14 questionnaires before administration of the therapy and every week, via telephone, to the patient (T0, T1S, T2S, T3S, T1M, T5S, T6S, T7S, T2M, T9S, T10S, T11S, T3M, T13S, T14S, T15S, T4M).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: botulinum toxin | Active comparator | Drug: Botulinum toxin type A injectionThe botulinum toxin injection will be carried out by a doctor with experience in this therapeutic modality, which in turn is not part of the group of doctors who observe patients in the initial and subsequent phases. 100 Units (U) of botulinum toxin type A, in each lower limb (200 U in total), in muscle proximal thigh, once, at a moment that will be defined as T0. This group of 10 participans. |
| Active Comparator: Placebo | Placebo comparator | Drug: Botulinum toxin type A injectionIn the control group, patients will be subject to the same protocol, with the difference in that the injections will be saline, although they look the same on the outside. You doctors carrying out therapy and evaluating progress during face-to-face visits will not have access to the distribution of groups. This group of 10 participans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 type A injectionThe BT injection will be performed by a doctor with experience in this therapy, with 100 Units (U) of type A BT, bilaterally, in the flexor muscle of the thigh, once, with replacement of the same ampoules with saline in controls. To the Patient assessments will take place over 4 months, weekly by telephone using a questionnaires on freezing and the notion of clinical improvement (FOGQ and SCGIC, respectively) and monthly in person with objective assessments using the MDS-UPDRS scales - part III motor assessment, Timed Up \& Go and Two Minute Walk. | Drug | Active Comparator: Placebo, Active Comparator: botulinum toxin |
Primary outcome
Variation Unified Parkinson's Disease Rating Scale (MDS-UPDRS8)
Time frame: for 4 months after the study
which is defined as fever (auricular temperature >38ºC) and elevation of CRP (> 75 mg/L), during the first 3 days after operation.
Variation Escala "Timed Up & Go"11
Time frame: for 4 months after the study
20% improvement in completion time in any reevaluations;
Variation Escala Two Minutes Walk12
Time frame: for 4 months after the study
20% improvement in the distance covered in any reevaluations;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Freezing of Gate
Recruiting
Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
Parkinson Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A injection in people with Freezing of Gate and Parkinson Disease, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Portugal. 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.
Are results available for this study?
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?
Variation Unified Parkinson's Disease Rating Scale (MDS-UPDRS8) (time frame: for 4 months after the study). The study lists 3 primary outcomes in all. 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 23 Oct 2023.