Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-14

Study Completion Date

2021-06-08

Brief Summary

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In summary, this piot study with 6 participants shown that recombinant human growth hormone (rhGH) has a positive effect on the treatment with PMS. In addition, This study indicated that rhGH can improve PMS symptoms via increase the level of serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein 3 (IGFBP-3). RhGH may be low cost, more accessible, alternative treatment for PMS.

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Detailed Description

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Compared with the placebo, rhGH treatment significantly decreased the total scores and subscale scores of GDS (P \<0.05), while the total scores and subscale scores of SC-ABC significantly decreased (P \< 0.05) following three-months rhGH treatment. The similar results were also observed in comparison with baseline. Compared with the baseline, the level of serum IGF-1 and IGFBP-3 increased significantly (P \< 0.05) following three-months rhGH treatment, while the placebo group had no significant impact on serum IGF-1 and IGFBP-3 (P \> 0.05). One participant developed skin allergy the day after the first rhGH treatment, which were resolved later.

Conditions

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Phelan-McDermid Syndrome Growth Hormone Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Subjects were randomly divided into two different groups. Group A began with placebo while group B with rhGH. Randomisation of the treatment order (i.e., starting with rhGH or placebo) was done through a permuted four-block designed by the physician, who was the only one not blinded for treatment allocation.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline was started at 0.1 IU/kg once daily as the placebo

Group B

Subjects were randomly divided into two different groups. Group A began with placebo while group B with rhGH. Randomisation of the treatment order (i.e., starting with rhGH or placebo) was done through a permuted four-block designed by the physician, who was the only one not blinded for treatment allocation.

Group Type EXPERIMENTAL

recombinant human growth hormone

Intervention Type DRUG

RhGH treatment was started at 0.1 IU/kg once daily

Interventions

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recombinant human growth hormone

RhGH treatment was started at 0.1 IU/kg once daily

Intervention Type DRUG

Saline

Saline was started at 0.1 IU/kg once daily as the placebo

Intervention Type DRUG

Other Intervention Names

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rhGH (Changchun Jinsai Pharmaceutical Co., Ltd, S20080011)

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with PMS aged from 1years to 5 years

Exclusion Criteria

\- active or suspected tumour, intracranial hypertension, chronic kidney disease, acute proliferative or severe nonproliferative diabetic retinopathy, allergy to rhGH or severe comorbidity

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes